Hepatocellular Carcinoma (HCC)NCT03138239
The Potential Role of Ga-68-PSMA in Staging, Restaging and Monitoring Response in Primary Liver Cancer: Comparison With F-18-FDG
A study testing Ga-68-PSMA scan, and PET -CT F-18-FDG in people with Hepatocellular Carcinoma (HCC), run by Tel-Aviv Sourasky Medical Center.
Trial summary
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world. The staging of the disease is done by combining blood tests and imaging tests. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Ga-68-PSMA scan, and PET -CT F-18-FDG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2017to 2 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 16 patients diagnosed with HCC.
Who cannot join
- Minors under the age of 18
- Pregnant women
- People without primary liver cancer
About this study
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world.
The staging of the disease is done by combining blood tests and imaging tests. Ultrasound scanning, computed tomograph (CT) and magnetic resonance imaging (MRI) scans are methods based on identifying or significant change in the liver.
Read more
Those changes are sometimes difficult to identify, especially when there are changes in liver structure resulting from disease, such as cirrhosis of the liver.
In many cases it is also difficult to detect secondary scattering in anatomical tests, such as identifying a disease in normal size lymph nodes or early skeletal dissociation.
Functional imaging is not based on structural changes, but on the ability to detect changes in the function and properties of the tissue, such as a change in the cell's metabolic consumption or the presence of proteins that characterize the tumor tissue.PET scans can show tumor cell activity (the cancer cells are more aggressive, get more sugar and therefore see more absorption in PET), detect small tumors and metastases outside the liver (because they do a whole body test). To complete this test, a CT scan is also performed on the same device (PET-CT scanner).
There is a new material called prostate-specific mRNA that is marked with gallium isotope (Ga-68-PSMA). It is the substance that is absorbed into the cells of the blood vessels of the tumor. The Ga-68-PSMA is now widely used in the diagnosis of prostate cancer. The new researches also found the possibility of using Ga-68-PSMA in primary liver cancer in patients because of the over-expression of the antigen in the blood vessels.
Therefore, the tests with Ga-68-PSMA and F-18-FDG will complement each other and will give a complete picture of the extent of the disease.
Each patient has individual characteristics of the tumor, and according to the results it will be possible to adapt the test to the patient with the appropriate material for the disease and this will be effective for the decision to treat and follow up.
At the end of the study it will be possible to offer the study participant the appropriate functional imaging test.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Ga-68-PSMA scan, and PET -CT F-18-FDG
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68-PSMA scan, and PET -CT F-18-FDGRadiation
The patient will do tow mappings on two different days. It should be noted that there is no importance to the order between the two tests on the condition that they be performed within 7-10 days of each other.
Both tests will be performed with the Discovery 690 camera, which is located at the Nuclear Medicine Institute.
First test PET-CT with F-18-FDG PET-CT second test with Ga-68-PSMA
| Study group | Role | What they receive |
|---|---|---|
| 16 patients diagnosed with HCC | Experimental | * 12 patients will be tested at the stage of diagnosis (staging)
* 4 patients who have tested at staging, will be tested again after treatment.
* 4 patients with treatment failure or recurrence. Receives: Radiation: Ga-68-PSMA scan, and PET -CT F-18-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the absorption of PET-CT F-18-FDG and of PET -CT Ga-68-PSMA
Measuring it in patients with primary liver cancer at staging, restaging and monitoring response.
Measured: The duration of the entire study will last about one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start2 Jul 2017 (estimated)
- Primary completion2 Jul 2018 (estimated)
- Study completion2 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138239
- Sponsor's protocol ID
- TASMC-17-ES-0056-CTIL
- Status last verified
- Feb 2017
- First submitted
- 30 Apr 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of Ga-68-PSMA in Staging, Restaging and Monitoring Response in Primary Liver Cancer: Comparison With F-18-FDG
- ClinicalTrials.gov ID
- NCT03138239
- Acronym / sponsor ID
- TASMC-17-ES-0056-CTIL
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 2 Jul 2017 (estimated)
- Primary completion
- 2 Jul 2018 (estimated)
- Study completion
- 2 Jul 2019 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world.
The staging of the disease is done by combining blood tests and imaging tests. Ultrasound scanning, computed tomograph (CT) and magnetic resonance imaging (MRI) scans are methods based on identifying or significant change in the liver.
Those changes are sometimes difficult to identify, especially when there are changes in liver structure resulting from disease, such as cirrhosis of the liver.
In many cases it is also difficult to detect secondary scattering in anatomical tests, such as identifying a disease in normal size lymph nodes or early skeletal dissociation.
Functional imaging is not based on structural changes, but on the ability to detect changes in the function and properties of the tissue, such as a change in the cell's metabolic consumption or the presence of proteins that characterize the tumor tissue.PET scans can show tumor cell activity (the cancer cells are more aggressive, get more sugar and therefore see more absorption in PET), detect small tumors and metastases outside the liver (because they do a whole body test). To complete this test, a CT scan is also performed on the same device (PET-CT scanner).
There is a new material called prostate-specific mRNA that is marked with gallium isotope (Ga-68-PSMA). It is the substance that is absorbed into the cells of the blood vessels of the tumor. The Ga-68-PSMA is now widely used in the diagnosis of prostate cancer. The new researches also found the possibility of using Ga-68-PSMA in primary liver cancer in patients because of the over-expression of the antigen in the blood vessels.
Therefore, the tests with Ga-68-PSMA and F-18-FDG will complement each other and will give a complete picture of the extent of the disease.
Each patient has individual characteristics of the tumor, and according to the results it will be possible to adapt the test to the patient with the appropriate material for the disease and this will be effective for the decision to treat and follow up.
At the end of the study it will be possible to offer the study participant the appropriate functional imaging test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16 patients diagnosed with HCC | Experimental | Radiation: Ga-68-PSMA scan, and PET -CT F-18-FDG* 12 patients will be tested at the stage of diagnosis (staging) * 4 patients who have tested at staging, will be tested again after treatment. * 4 patients with treatment failure or recurrence. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 16 patients diagnosed with HCC.
Key exclusion criteria (3 listed)
- Minors under the age of 18
- Pregnant women
- People without primary liver cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68-PSMA scan, and PET -CT F-18-FDGThe patient will do tow mappings on two different days. It should be noted that there is no importance to the order between the two tests on the condition that they be performed within 7-10 days of each other. Both tests will be performed with the Discovery 690 camera, which is located at the Nuclear Medicine Institute. First test PET-CT with F-18-FDG PET-CT second test with Ga-68-PSMA | Radiation | 16 patients diagnosed with HCC |
Primary outcome
Measure the absorption of PET-CT F-18-FDG and of PET -CT Ga-68-PSMA
Time frame: The duration of the entire study will last about one year.
Measuring it in patients with primary liver cancer at staging, restaging and monitoring response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-68-PSMA scan, and PET -CT F-18-FDG in people with Hepatocellular Carcinoma (HCC), run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the absorption of PET-CT F-18-FDG and of PET -CT Ga-68-PSMA (time frame: The duration of the entire study will last about one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.